Curved surgical fasteners for securing prosthetic devices to tissue

ABSTRACT

A curved surgical fastener for anchoring medical devices to tissue includes a curved member having a proximal end and a distal end. The distal end of the curved member has a tissue penetrating end including an insertion tip with a distal point. The curved member has a total curvature of less than 360 degrees between the proximal and distal ends of the curved member. The curved member comprises a compound curve. A proximal section of the curved member has a first radius of curvature and a distal section of the curved member has a second radius of curvature that is different than the first radius of curvature.

CROSS REFERENCE TO RELATED APPLICATIONS

The present patent application is related to commonly assigned U.S.Design patent application Ser. No. 29/509,958, filed Nov. 24, 2014, thedisclosure of which is hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to surgical fasteners, and morespecifically relates to curved surgical fasteners for securingprosthetic devices such as surgical mesh to tissue.

2. Description of the Related Art

Hernia is a condition whereby a small loop of bowel or intestineprotrudes through a weak place or defect within the abdominal musclewall or groin of a patient. This condition commonly occurs in humans,particularly males. Hernias may result from a congenital defect wherebythe patient is born with this problem, or may be caused by straining orlifting heavy objects. Heavy lifting has been found to create a largeamount of stress upon the abdominal wall, which can cause a rupture ortearing at a weak point of the abdominal muscle to create the defect oropening. In any Hernia case, a patient may be left with an unsightlybulge of intestinal tissue protruding through the defect, which mayresult in pain, reduced lifting abilities, and in some cases, impactionof the bowel, or possibly other complications if the flow of blood iscut off to the protruding tissue.

A common solution for correcting a hernia condition is surgery. During asurgical procedure, the defect is accessed and carefully examined,either through an open incision or endoscopically through an access portsuch as a trocar. In either case, careful examination is required due tothe network of vessels and nerves that exist in the area of a typicaldefect, which requires a surgeon to conduct a hernia repair with greatskill and caution. Within this area can be found vascular structuressuch as gastric vessels, the external iliac vessels, and the inferiorepigastric vessels, as well as reproductive vessels such as the vasdeferens extending through the inguinal floor.

Once the surgeon is familiar with the anatomy of a patient, the surgeoncarefully places the viscera back into the patient's abdomen through thedefect. Repairing the defect can involve closure of the defect withsutures or fasteners but generally involves placing a surgicalprosthetic such as a mesh patch over the open defect, and attaching themesh patch to the abdominal wall or inguinal floor using sutures orsurgical fasteners. The mesh patch acts as a barrier and preventsexpulsion of bowel through the defect.

Inguinal hernia repair involves the placement and fixation of a surgicalmesh over a defect. There are specific sites that must be avoided due tothe presence of blood vessels and nerves (known as the triangle of doomand triangle of pain), and specific sites that can be used for meshfixation (Cooper's ligament, Lacunar ligament, abdominal wall). TheCooper's ligament, also known as the Pectineal ligament, lies on thesuperior pubic ramus of the pelvis. The thickness of this ligament istypically 1 mm to 3 mm.

Suture is the standard for hernia mesh fixation and is used for affixingmesh to the Cooper's ligament. Suturing of the mesh patch to theinguinal floor can be well suited to open procedures. In laparoscopicprocedures, however, suturing is not preferred due to the greater skilland time required.

Adhesives have also been used for hernia mesh fixation, including fibrinand cyanoacrylate adhesives. The use of adhesives has been limited,however, due to high cost, special storage conditions, preparation, anddiminished effectiveness on wet tissue.

Self-adhering surgical mesh is also used for laparoscopic hernia repair.Some surgeons have noted some difficulty in handling due toself-adhesion. In addition, surgeons often prefer the additionalsecurity of mechanical fixation of the mesh to tissue.

Surgical fasteners are often used during endoscopic or open proceduresfor attaching mesh patches to the inguinal floor. One of the earliesttypes of endoscopic procedures involves the use of a surgical staplerthat dispenses staples into tissue. The surgical stapler typically has astack of unformed staples that are contained within a stapling cartridgein a serial fashion. The staples are sequentially advanced or fed withinan applicator instrument by a spring mechanism. As the staples aredispensed, an anvil engages the arms of the staple to bend the arms intoa closed, clamping position.

Another hernia mesh attachment instrument uses a helical wire fastenerthat resembles a small section of spring. Multiple helical wirefasteners may be stored serially within a shaft of an applicatorinstrument, and may be corkscrewed or rotated into tissue. A load springmay be used to bias or feed the plurality of helical fasteners distallywithin the shaft.

Surgical fasteners have generally been made of metal, such as stainlesssteel, nitinol, or titanium. The use of metal fasteners was necessary toprovide for sufficient holding strength, penetration of variousprosthetic meshes, and for ease of manufacture. Although metallic meshfixation devices are very effective at securing mesh to the Cooper'sligament, it is suspected that metallic devices contribute to long-termpatient pain and discomfort.

In response to problems associated with using permanent, metalfasteners, absorbable mesh fixation devices have been developed forsecuring mesh to tissue. Until recently, there were no absorbable tissuefasteners available on the market, and surgeons could only useabsorbable sutures in order to provide a fixation means that did notpermanently stay in the body. However, using sutures is exceedinglydifficult for laparoscopic procedure, and so they are generally not usedunless the repair is done in an open fashion. With surgical trendsleading to more minimally invasive techniques with minimum foreign bodyaccumulation, there remains a need for absorbable tissue fasteners foraffixing mesh to tissue that can be applied laparoscopically, wherebythe tissue fastener has a minimum profile.

Thus, in spite of the above advances, there remains a need for furtherimprovements in surgical fasteners. In particular, there remains a needfor surgical fasteners having a minimum profile, surgical fastenershaving smaller profiles, surgical fasteners that achieve sufficientanchoring force in tissue, surgical fasteners that may be appliedlaparoscopically, surgical fasteners that have superior holdingstrength, surgical fasteners that will not injure vessels and nerves,and surgical fasteners that are absorbable.

SUMMARY OF THE INVENTION

The present patent application discloses a curved surgical fastener forsecuring a prosthetic device such as a surgical mesh to tissue. In oneembodiment, the curved surgical fastener has a curved tissue penetratingpoint located at the distal-most end thereof. The size and length of thecurvature controls the depth of penetration of the curved surgicalfastener into tissue, and the pull force required to extract the curvedsurgical fastener from the tissue. The curvature at the proximal end ofthe curved member preferably has a captivating geometry that effectivelycaptures a surgical mesh at the proximal end. The captivating geometrymay have a radius or tangent section for securing the mesh. The surgicalmesh may also be secured at the initial penetration and locked inposition by a barb located at the proximal end of the curved surgicalfastener. Although the present invention is not limited by anyparticular theory of operation, it is believed that the embodimentsdisclosed herein provide low profile shallow depth tissue anchors thateffectively secure mesh in areas where tissue thickness is relativelythin or is a concern.

In one embodiment, the curved surgical fastener desirably includes anelongated, curved member having a proximal and a distal end, whereby thecurved member has a total curvature of less than 360 degrees extendingfrom the proximal end to the distal end in a first plane. The curvedsurgical fastener desirably has a tissue penetrating geometry at thedistal end and a surgical mesh captivating geometry near the proximalend.

In one embodiment, the curved member includes a compound curve havingmore than one radius. In one embodiment, the total curvature of thesurgical fastener extends into a second plane located above the firstplane of the fastener. In one embodiment, the total curvature of thesurgical fastener extends into a second plane below the first plane ofthe fastener.

In one embodiment, the curved surgical fastener has a barb-like featureadjacent the distal end for engaging tissue. The mesh captivatinggeometry at the proximal end of the curved member may have a radius or atangent section.

In one embodiment, at least one structural feature, such as a barb, islocated on the proximal end of the surgical fastener for capturing asection of the surgical mesh.

In one embodiment, a curved surgical fastener for anchoring medicaldevices to tissue preferably includes a curved member having a proximalend and a distal end whereby the curved member has a total curvature ofless than 360 degrees between the proximal and distal ends. The distalend of the curved member desirably has a tissue penetrating endincluding an insertion tip having a distal point. In one embodiment, thetissue penetrating end of the curved member may be curved and/ortapered.

In one embodiment, the curved member lies in a single plane. In oneembodiment, the proximal end of the curved member lies in a first planeand the distal end of the curved member lies in a second plane that isoffset from the first plane. In one embodiment, the curved member has anintermediate section that extends between the first plane at theproximal end of the curved member and the second plane at the distal endof the curved member.

In one embodiment, the curved member comprises a compound curve. In oneembodiment, a proximal section of the curved member preferably has afirst radius of curvature and a distal section of the curved memberpreferably has a second radius of curvature that is different than thefirst radius of curvature. In one embodiment, the first radius ofcurvature is smaller than the second radius of curvature.

In one embodiment, the proximal end of the curved member includes atang, such as a straight tang. When the curved surgical fastener isinserted into tissue, the tang preferably engages a surgical mesh forsecuring the surgical mesh to the tissue.

In one embodiment, the curved member preferably includes one or morebarbs projecting therefrom. In one embodiment, the one or more barbsproject from the tissue penetrating end of the curved member. In oneembodiment, the one or more barbs project from the insertion tip at thedistal end of the curved member. The one or more barbs desirably projectway from the distal end of the curved member and toward the proximal endof the curved member.

In one embodiment, the curved surgical fastener desirably includes asecond barb projecting from the proximal end of the curved member. Thesecond barb preferably projects toward the distal end of the curvedmember. When the curved surgical fastener is inserted into tissue, thesecond barb preferably engages a surgical mesh for securing the surgicalmesh to the tissue.

In one embodiment, the curved surgical fastener may include one or moresupplemental barbs projecting from an intermediate section of the curvedmember that is located between the proximal and distal ends of thecurved member. The one or more supplemental barbs preferably projectaway from the distal end of the curved member and toward the proximalend of the curved member. When the curved surgical fastener is insertedinto tissue, the one or more supplemental barbs preferably engage thetissue for preventing the curved member from being extracted or pulledout of the tissue. In one embodiment, the one or more supplemental barbsinclude a plurality of barbs projecting from the intermediate section ofthe curved member.

In one embodiment, a curved surgical fastener for anchoring medicaldevices to tissue preferably includes a curved member having a proximalend and a distal end, a curved tissue penetrating end at the distal endof the curved member, and a barb projecting from the distal end of thecurved member. The curved member desirably has a total curvature of lessthan 360 degrees between the proximal and distal ends. A proximalsection of the curved member desirably has a different radius ofcurvature than a distal section of the curved member.

In one embodiment, the curved member preferably defines a compound curvewith the proximal end of the curved member lying in a first plane andthe distal end of the curved member lying in a second plane that isoffset from the first plane.

In one embodiment, a curved surgical fastener for anchoring medicaldevices to tissue desirably includes a curved member having a proximalend and a distal end, the curved member defining a compound curve havinga total curvature of less than 360 degrees between the proximal anddistal ends of the curved member, whereby the distal end of the curvedmember includes a tissue penetrating end having an insertion tip with adistal point defining a distal-most end of the curved surgical fastener.

In one embodiment, the surgical fastener is absorbable. The surgicalfastener may be made of metal.

In one embodiment of the present invention, the distal points on theinsertion tips may have facets. In other embodiment, however, the distalpoints on the insertion tips may have smooth surfaces such as conicalshaped distal points.

In one embodiment, the insertion tips are cut or have defined chiselpoints, which enable the insertion tips to cut during insertion, therebyimproving the ability of the curved surgical fasteners to penetratedifficult materials such as GORE® dual mesh. Insertion tips havingcompound cut or chiseled angles may also be used to allow for stronger,yet shorter tip designs.

In one embodiment, curved surgical fasteners may have conical-shapedinsertion tips that create a puncture rather than a cut, therebyimproving holding force. Although the present invention is not limitedby any particular theory of operation, it is believed thatconical-shaped insertion tips create only a single point of stressconcentration, whereby the section of the curved surgical fastener thatfollows must expand the hole radially. It is believed that this may makeit harder for the rest of the curved surgical fastener to make itthrough the hole, but may potentially increase retention forces bymaking a tighter hole.

In one embodiment, curved surgical fasteners may incorporate activeagents such anti-microbials and anti-adhesion materials. In oneembodiment, curved surgical fasteners may incorporate radio-opacity toenable the curved surgical fasteners to be visible on x-ray imagingmachines.

These and other preferred embodiments of the present invention will bedescribed in more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a curved surgical fastener, inaccordance with one embodiment of the present invention.

FIG. 1B is a front elevation view of the curved surgical fastener shownin FIG. 1A.

FIG. 1C is a right side view of the curved surgical fastener shown inFIG. 1A.

FIG. 1D is a left side view of the curved surgical fastener shown inFIG. 1A.

FIG. 1E is a top view of the curved surgical fastener shown in FIG. 1A.

FIG. 1F is a bottom view of the curved surgical fastener shown in FIG.1A.

FIG. 2A is a perspective view of a curved surgical fastener, inaccordance with a second embodiment of the present invention.

FIG. 2B is a front elevation view of the curved surgical fastener shownin FIG. 2A.

FIG. 2C is a right side view of the curved surgical fastener shown inFIG. 2A.

FIG. 2D is a left side view of the curved surgical fastener shown inFIG. 2A.

FIG. 2E is a top plan view of the curved surgical fastener shown in FIG.2A.

FIG. 2F is a bottom view of the curved surgical fastener shown in FIG.2A.

FIG. 3A is a perspective view of a curved surgical fastener, inaccordance with a third embodiment of the present invention.

FIG. 3B is a front elevation view of the curved surgical fastener shownin FIG. 3A.

FIG. 3C is a right side view of the curved surgical fastener shown inFIG. 3A.

FIG. 3D is a left side view of the curved surgical fastener shown inFIG. 3A.

FIG. 3E is a top plan view of the curved surgical fastener shown in FIG.3A.

FIG. 3F is a bottom view of the curved surgical fastener shown in FIG.3A.

FIG. 4A is a perspective view of a curved surgical fastener, inaccordance with a fourth embodiment of the present invention.

FIG. 4B is a front elevation view of the curved surgical fastener shownin FIG. 4A.

FIG. 4C is a right side view of the curved surgical fastener shown inFIG. 4A.

FIG. 4D is a left side view of the curved surgical fastener shown inFIG. 4A.

FIG. 4E is a top plan view of the curved surgical fastener shown in FIG.4A.

FIG. 4F is a bottom view of the curved surgical fastener shown in FIG.4A.

FIG. 5A is a perspective view of a curved surgical fastener, inaccordance with a fifth embodiment of the present invention.

FIG. 5B is a front elevation view of the curved surgical fastener shownin FIG. 5A.

FIG. 5C is a right side view of the curved surgical fastener shown inFIG. 5A.

FIG. 5D is a left side view of the curved surgical fastener shown inFIG. 5A.

FIG. 5E is a top plan view of the curved surgical fastener shown in FIG.5A.

FIG. 5F is a bottom view of the curved surgical fastener shown in FIG.5A.

FIG. 6A is a perspective view of a curved surgical fastener, inaccordance with a sixth embodiment of the present invention.

FIG. 6B is a front elevation view of the curved surgical fastener shownin FIG. 6A.

FIG. 6C is a right side view of the curved surgical fastener shown inFIG. 6A.

FIG. 6D is a left side view of the curved surgical fastener shown inFIG. 6A.

FIG. 6E is a top plan view of the curved surgical fastener shown in FIG.6A.

FIG. 6F is a bottom view of the curved surgical fastener shown in FIG.6A.

FIG. 7A is a perspective view of a curved surgical fastener, inaccordance with a seventh embodiment of the present invention.

FIG. 7B is a front elevation view of the curved surgical fastener shownin FIG. 7A.

FIG. 7C is a right side view of the curved surgical fastener shown inFIG. 7A.

FIG. 7D is a left side view of the curved surgical fastener shown inFIG. 7A.

FIG. 7E is a top plan view of the curved surgical fastener shown in FIG.7A.

FIG. 7F is a bottom view of the curved surgical fastener shown in FIG.7A.

FIG. 8A shows an exploded view of an applicator instrument fordispensing curved surgical fasteners, in accordance with one embodimentof the present invention.

FIGS. 8B-8C show a method of using the applicator instrument of FIG. 8Afor dispensing curved surgical fasteners, in accordance with oneembodiment of the present invention.

FIG. 9 shows a perspective view of curved surgical fasteners securing asurgical mesh to tissue, in accordance with one embodiment of thepresent invention.

FIG. 10 shows a curved surgical fastener having a pointed distal endsecuring a surgical mesh to tissue, in accordance with one embodiment ofthe present invention.

FIG. 11 shows a curved surgical fastener having a barb at a distal endthereof securing a surgical mesh to tissue, in accordance with oneembodiment of the present invention.

FIG. 12 shows a curved surgical fastener having a pointed distal end anda tang at a proximal end securing a surgical mesh to tissue, inaccordance with one embodiment of the present invention.

DETAILED DESCRIPTION

Referring to FIGS. 1A-1F, in one embodiment, a curved surgical fastener120 preferably includes a curved member 122 having a proximal end 124and a distal end 126. The curved surgical fastener 120 desirablyincludes a tissue penetrating end 28 located at the distal-most end ofthe curved member 122. The tissue penetrating end 128 is preferablytapered. In one embodiment, the tissue penetrating end 128 is curved. Adistal end of the tissue penetrating end 128 preferably includes aninsertion tip 130 having a distal point 132 that facilitates insertionof the tissue penetrating end 128 of the curved member 122 into tissue.

Referring to FIGS. 1A and 1B, in one embodiment, the curved member 122has a total curvature between the proximal end 124 and the distal end126 of less than 360 degrees. In one embodiment, the curved member 122preferably forms a compound curve. As used herein, the terminologycompound curve defines a curve made up of two or more circular arcs ofsuccessively shorter or longer radii, joined tangentially withoutreversal of curvature. Compound curves are often used on railroad tracksand highways as an easement curve to provide a less abrupt transitionfrom tangent to full curve or vice versa.

In one embodiment, a proximal section 134 of the curved member 122 has afirst radius of curvature and a distal section 136 of the curved member122 has a second radius of curvature that is different than the firstradius of curvature. In one embodiment, the first radius of curvature issmaller than the second radius of curvature. In one embodiment, thefirst radius of curvature of the proximal section 134 of the curvedmember 122 is about 1.5 mm, and the second radius of curvature of thedistal section 136 of the curved member 122 is about 2.5 mm. In oneembodiment, the curved surgical fastener 120 has an outer diameter D1 ofabout 4.5 mm.

The size and length of the curvature of the curved member 122 preferablycontrols the penetration depth of the curved surgical fastener intotissue, and the anchoring force exerted by the curved surgical fastenerafter it has been inserted into tissue. The proximal end 124 of thecurved member 122 preferably has a geometry that is adapted to capture asurgical mesh at the proximal end of the device. The geometry at theproximal end 124 of the curved member 122 may have a radius or tangentsection for capturing the surgical mesh. The mesh may also be securedvia initial penetration of the curved surgical fastener through themesh, and locked in position by a barb located at the proximal end ofthe curved member. Although the present invention is not limited by anyparticular theory of operation, it is believed that the curved designshaving a curvature of less than 360 degrees will provide a low profileshallow depth tissue anchor that is suitable for securing surgical meshin areas where tissue thickness is a concern.

In one embodiment, the curved surgical fastener may be made ofabsorbable and/or non-absorbable materials. Preferred absorbablematerials include PDS, PDS/lactide-glycolide blends, PLA, etc. In oneembodiment, each curved surgical fastener is sized to fit inside of a 5mm outer diameter tube (typically trocar cannula dimension). The curvedsurgical fastener is fabricated by molding, however, with smallmodifications, other processes such as casting, stamping, and machiningmay be used. In one embodiment, the curved surgical fastener may beextruded into a general shape, and then formed.

Referring to FIGS. 1C-1F, in one embodiment, the curved member 122 ofthe curved surgical fastener 120 lies in a single plane P1.

Referring to FIGS. 2A-2F, in one embodiment, a curved surgical fastener220 is generally similar to that shown above in FIGS. 1A-1F, but has acurved member 222 having a larger radius of curvature than the deviceshown in FIGS. 1A-1F. In one embodiment, the curved member 222 has aproximal end 224, a distal end 226, and a tissue penetrating end 228located at the distal-most end of the curved member 222. The tissuepenetrating end 228 is preferably curved and/or tapered. A distal end ofthe tissue penetrating end 228 desirably has an insertion tip 230 havinga point 232 that facilitates insertion of the curved member 222 intotissue.

Referring to FIGS. 2A and 2B, in one embodiment, the curved member 222has a total curvature between the proximal end 224 and the distal end226 of less than 360 degrees. In one embodiment, the curved member 222defines a compound curve having a proximal section 234 with a firstradius of curvature and a distal section 236 with a second radius ofcurvature that is larger than the first radius of curvature. In oneembodiment, the first radius of curvature of the proximal section 234 ofthe curved member 222 is about 1.5 mm, and the second radius ofcurvature of the distal section 236 of the curved member 222 is about2.5 mm. In one embodiment, the curved surgical fastener 220 has an outerdiameter D2 of about 4.5 mm.

Referring to FIGS. 2C-2F, in one embodiment, the curved member 222 ofthe curved surgical fastener 220 lies in a single plane P2.

Referring to FIGS. 3A-3F, in one embodiment, a curved surgical fastener320 preferably includes a curved member 322 having a proximal end 324and a distal end 326. The curved surgical fastener 320 desirablyincludes a tissue penetrating end 328 located at the distal-most end ofthe curved member 322. The tissue penetrating end 328 is preferablytapered and/or curved. A distal end of the tissue penetrating end 328preferably has an insertion tip 330 having a distal point 332 thatfacilitates insertion of the distal end 326 of the curved member 322into tissue.

Referring to FIGS. 3A and 3B, in one embodiment, the proximal end 324 ofthe curved member 322 has a tang 340 projecting therefrom. The tang 340may define a straight section of the device 320 and is adapted to engagea surgical mesh for securing the surgical mesh to tissue.

In one embodiment, the curved member 322 has a total curvature betweenthe proximal end 324 and the distal end 326 of less than 360 degrees. Inone embodiment, the curved member 322 is a compound curve with aproximal section 334 having a first radius of curvature and a distalsection 336 having a second radius of curvature that is larger than thefirst radius of curvature. In one embodiment, the first radius ofcurvature of the proximal section 334 of the curved member 322 is about1.5 mm, and the second radius of curvature of the distal section 336 ofthe curved member 322 is about 2.5 mm. In one embodiment, the curvedsurgical fastener 320 has an outer diameter D3 of about 4.5 mm.

Referring to FIGS. 3C-3F, in one embodiment, the curved member 322 ofthe curved surgical fastener 320 lies in a single plane P3.

Referring to FIGS. 4A-4F, in one embodiment, a curved surgical fastener420 preferably includes a curved member 422 having a proximal end 424and a distal end 426. The curved surgical fastener 420 desirablyincludes a tissue penetrating end 428 located at the distal-most end ofthe curved member 422. The tissue penetrating end 428 is preferablytapered and/or curved. A distal end of the tissue penetrating end 428preferably has an insertion tip 430 having a distal point 432 thatfacilitates insertion of the distal end 426 of the curved member 422into tissue.

Referring to FIGS. 4A and 4B, in one embodiment, the curved surgicalfastener 420 preferably includes a barb 442 projecting from the tissuepenetrating end 428. The barb 442 desirably projects away from thedistal end 426 of the curved member 422. After the insertion tip 430 isadvanced into tissue, the barb 442 is adapted to hold the curved member422 in place and prevent retraction and/or pullout of the curved memberfrom the tissue.

In one embodiment, the curved member 422 has a total curvature betweenthe proximal end 424 and the distal end 426 of less than 360 degrees. Inone embodiment, the curved member defines a compound curve having aproximal section 434 with a first radius of curvature and a distalsection 436 with a second radius of curvature that is different than thefirst radius of curvature. In one embodiment, the first radius ofcurvature is smaller than the second radius of curvature. In oneembodiment, the first radius of curvature of the proximal section 434 ofthe curved member 422 is about 1.5 mm, and the second radius ofcurvature of the distal section 436 of the curved member 422 is about2.5 mm. In one embodiment, the curved surgical fastener 420 has an outerdiameter D4 of about 4.5 mm.

Referring to FIGS. 4C-4F, in one embodiment, the curved member 422 ofthe curved surgical fastener 420 lies in a single plane P4.

Referring to FIGS. 5A-5F, in one embodiment, a curved surgical fastener520 has a curved member 522 having a larger radius of curvature than thecurved surgical fastener shown in FIGS. 4A-4F. In one embodiment, thecurved member 522 has a proximal end 524, a distal end 526, and a tissuepenetrating end 528 located at the distal-most end of the curved member522. The tissue penetrating end 528 is preferably curved and/or tapered.A distal end of the tissue penetrating end 528 desirably has aninsertion tip 530 having a distal point 532 that facilitates insertionof the distal end 526 of the curved member 522 into tissue.

Referring to FIGS. 5A and 5B, in one embodiment, the curved surgicalfastener 520 preferably includes a barb 542 projecting from the tissuepenetrating end 528. The barb 542 desirably projects away from thedistal end 526 of the curved member 522. After the insertion tip 530 isadvanced into tissue, the barb 542 is adapted to hold the curved member522 in place and prevent retraction of the curved member from thetissue.

In one embodiment, the curved member 522 has a total curvature betweenthe proximal end 524 and the distal end 526 of less than 360 degrees. Inone embodiment, the curved member 522 has a constant radius of curvaturebetween the proximal end 524 of the curved member and the tapered tissuepenetrating end 528. Unlike the embodiments shown in FIGS. 1A-1F through4A-4F above, the curved member 522 shown in FIGS. 5A-5F does not form acompound curve. In one embodiment, the radius of curvature of the curvedmember 522 is about 2.5 mm. In one embodiment, the curved surgicalfastener 520 has an outer diameter D5 of about 5 mm.

Referring to FIGS. 5C-5F, in one embodiment, the curved member 522 ofthe curved surgical fastener 520 lies in a single plane P5.

Referring to FIGS. 6A-6F, in one embodiment, a curved surgical fastener620 includes a curved member 622 having a proximal end 624, a distal end626, and a tissue penetrating end 628 located at the distal-most end ofthe curved member 622. In one embodiment, the curved surgical fastener620 has an insertion tip 630 located at the distal end of the tissuepenetrating end 628. The distal-most end of the insertion tip 630 has adistal point 632 that facilitates insertion of the distal end 626 of thecurved member 622 into tissue.

Referring to FIGS. 6A and 6B, in one embodiment, the curved surgicalfastener 620 preferably includes a barb 642 projecting from theinsertion tip 630. The barb 642 desirably projects away from the distalpoint 632 of the insertion tip 630. After the insertion tip 630 isadvanced into tissue, the barb 642 is adapted to hold the curved member622 in place and prevent retraction of the curved member from thetissue.

In one embodiment, the curved member 622 has a total curvature betweenthe proximal end 624 and the distal end 626 of less than 360 degrees. Inone embodiment, the curved member 622 forms a compound curve having aproximal section 634 with a first radius of curvature and a distalsection 636 with a second radius of curvature that is different than thefirst radius of curvature. In one embodiment, the first radius ofcurvature is smaller than the second radius of curvature. In oneembodiment, the first radius of curvature of the proximal section 634 ofthe curved member 622 is about 2.5 mm, and the second radius ofcurvature of the distal section 636 of the curved member 622 is about2.5 mm. In one embodiment, the curved surgical fastener 620 has an outerdiameter D6 of about 5 mm.

Referring to FIGS. 6C-6F, in one embodiment, the proximal end 624 of thecurved member 622 lies in a first plane P6, and the distal end 626 ofthe curved member 622 lies in a second plane P6′ that is offset from thefirst plane P6. The curved member 622 desirably has an intermediatesection 625 that interconnects the respective proximal and distal ends624, 626 of the curved member 622 as the curved member transitions fromthe first plane P6 to the second plane P6′. Although the presentinvention is not limited by any particular theory of operation, it isbelieved that providing a curved surgical fastener that extends into twodifferent planes enhances the anchoring force of the fastener in tissueand makes it more difficult to extract the fastener from the tissue.

Referring to FIGS. 7A-7F, in one embodiment, a curved surgical fastener720 includes a curved member 722 having a proximal end 724, a distal end726, and a tissue penetrating end 728 located at the distal end of thecurved member 722. The tissue penetrating end 728 is preferably taperedand/or curved. In one embodiment, the curved surgical fastener 720 hasan insertion tip 730 located at the distal end of the tissue penetratingend 728. The distal-most end of the insertion tip 730 has a distal point732 that facilitates insertion of the curved member 722 into tissue.

Referring to FIGS. 7A and 7B, in one embodiment, the curved surgicalfastener 720 preferably includes a distal barb 742 projecting from theinsertion tip 730. The distal barb 742 desirably projects away from thepoint 732 of the insertion tip 730. The curved surgical fastener 720also desirably includes one or more intermediate barbs 750 projectingfrom an intermediate section 725 of the curved member 722, and aproximal barb 752 projecting from the proximal end 724 of the curvedmember 722. After the insertion tip 730 is advanced into tissue, thedistal barb 742 and the one or more intermediate barbs 750 are adaptedto hold the curved member 722 in place and prevent retraction of thecurved member from the tissue. The proximal barb 752, which projectsaway from the proximal end of the curved member, is adapted to engage asurgical mesh for securing the surgical mesh to tissue.

In one embodiment, the proximal end 724 of the curved member 722 has atang 740 projecting therefrom. The tang 740 may define a straightsection of the device 720 and is adapted to engage a prosthetic devicesuch as a surgical mesh for securing the surgical mesh to tissue.

In one embodiment, the curved member 722 has a total curvature betweenthe proximal end 724 and the distal end 726 of less than 360 degrees. Inone embodiment, the curved member 722 forms a compound curve having aproximal section 734 with a first radius of curvature and a distalsection 736 with a second radius of curvature that is different than thefirst radius of curvature. In one embodiment, the first radius ofcurvature is smaller than the second radius of curvature. In oneembodiment, the first radius of curvature of the proximal section 734 ofthe curved member 722 is smaller than the second radius of curvature ofthe distal section 736 of the curved member 722.

Referring to FIGS. 7C-7F, in one embodiment, the proximal end 724 of thecurved member 722 lies in a first plane P7, and the distal end 726 ofthe curved member 722 lies in a second plane P7′ that is offset from thefirst plane P7. The curved member 722 desirably has an intermediatesection 725 that interconnects the respective proximal and distalsections 724, 726 of the curved member 722 as the curved membertransitions from the first plane P7 to the second plane P7′.

In one embodiment, the curved surgical fastening devices are used forsecuring prosthetic devices such as surgical mesh to tissue. In oneembodiment, after a surgical mesh is placed over tissue, the insertiontip at the distal end of a curved member is advanced through the meshand into the tissue. When properly inserted into tissue, the distal endof the curved member is disposed within the tissue and the proximal endof the curved member is in contact with the surgical mesh for securingthe surgical mesh to tissue.

In one embodiment, an applicator instrument may be used for insertingthe curved surgical fastening devices into tissue. Referring to FIG. 8A,in one embodiment, an applicator instrument 860 preferably has an outershaft 862 having a proximal end 864, a distal end 866 and a centralconduit 868 extending from the proximal end to the distal end of theouter shaft. The outer shaft 862 has internal threads 870 located at theproximal end of the outer shaft 862. The applicator instrument 860preferably has an inner shaft 872 having a proximal end 874 and a distalend 876. The proximal end 874 of the inner shaft 872 has externalthreads 878 that are adapted to mesh with the internal threads 870 ofthe outer shaft 862 for connecting the outer and inner shafts together.

In one embodiment, an actuating rod 880 desirably extends from theproximal end 874 of the inner shaft 872. The applicator instrument 860includes a handle 882 that is securable to the proximal end of theactuating shaft 880. A pin may be used for connecting the handle and theactuating rod together. In one embodiment, rotating the handle 882simultaneously rotates the actuating rod 880 and the inner shaft 872. Asthe inner shaft 872 rotates relative to the outer shaft 862, theexternal threads 878 on the inner shaft 872 engage the internal threads870 on the outer shaft 862 for moving the inner shaft toward the distalend of the outer shaft.

FIG. 8B shows the applicator instrument 860 of FIG. 8A with the innershaft 872 in a retracted position relative to the outer shaft 862. Whenthe inner shaft 872 is retracted, the underside of the handle 882 isspaced from the proximal end 864 of the outer shaft 862. A curvedsurgical fastening device, such as the curved surgical fastening device620 shown FIGS. 6A-6F of the present patent application, is loaded ontothe distal end of the inner shaft 872.

Referring to FIG. 8C, in one embodiment, when the handle 882 is rotatedin a clockwise or corkscrew-like manner, the actuating rod 880 isrotated about its longitudinal axis, which is turn rotates the innershaft 872 about its longitudinal axis relative to the outer shaft 862.The engagement of the inner threads 870 of the outer shaft 862 with theouter threads 878 of the inner shaft 872 moves the inner shaft towardthe distal end 866 of the outer shaft 862 until the curved surgicalfastening device 620 is advanced through a surgical mesh and intotissue. In one embodiment, the curved surgical fastener is advanced intothe tissue via a corkscrew-like motion. Distal advancement of the innershaft 872 relative to the outer shaft 862 is halted when the undersideof the handle 882 engages the proximal end 864 of the outer shaft 862.

Referring to FIGS. 9 and 10, in one embodiment, a prosthetic device suchas surgical mesh SM is positioned over tissue T. A first curved surgicalfastening device 120 similar to that shown and described above in FIGS.1A-1F is inserted through the surgical mesh SM and into tissue T so thatthe insertion tip 130, the tissue penetrating end 128, and the distalend of the curved member are disposed within the tissue T and theproximal end 124 of the curved member 122 overlies the top surface ofthe surgical mesh SM. The proximal end 124 of the curved member 22preferably engages the surgical mesh SM for securing the surgical meshto the tissue T.

Referring to FIGS. 9 and 11, in one embodiment, a second curved surgicalfastening device 620 similar to that shown and described above in FIGS.6A-6F is inserted through the surgical mesh SM and into tissue T so thatthe insertion tip 630, the tissue penetrating end 628, and the distalend of the curved member 622 are disposed within the tissue and theproximal end 624 of the curved member 622 overlies the top surface ofthe surgical mesh SM. The curved surgical fastening device 620 has abarb 642 that projects from the insertion tip 630. After the curvedsurgical fastening device 620 has been inserted into the tissue T, thebarb 642 preferably prevents the curved member 622 from being retractedfrom the tissue T. The proximal end 624 of the curved member 622preferably engages the surgical mesh SM for securing the surgical meshto the tissue T.

Referring to FIGS. 9 and 12, in one embodiment, a third curved surgicalfastening device 320 similar to that shown and described above in FIGS.3A-3F is inserted through the surgical mash SM and into tissue T so thatthe insertion tip 330, the tissue penetrating end 328, and the distalend of the curved member 322 are disposed within the tissue T and thetang 340 at the proximal end 324 of the curved member 322 overlies thetop surface of the surgical mesh SM. After the curved surgical fasteningdevice 320 has been inserted into the tissue T, the tang 340 at theproximal end 324 of the curved member 322 preferably engages thesurgical mesh SM for securing the surgical mesh to the tissue T.

The dimensions of the curved members disclosed herein (e.g., radius ofcurvature and diameter) may change depending upon the materials used tomake the surgical fasteners, such as a polymer material versus a metal.The dimensions of the curved members may also change depending uponwhere in the body the surgical fasteners are intended to be used. In oneembodiment, the pitch of the helix may be less in instances where ashallow tissue penetration is required. In one embodiment, the radii ofcurvature of the curved members may be smaller and the materialdiameters may be less if the material used is a metal.

Although the present invention is not limited by any particular theoryof operation, it is believed that providing curved surgical fastenerswill provide enhanced control over the penetration depth and pull force.The curved design provides a low profile shallow depth anchor useful forsecuring surgical mesh to tissue in areas where the tissue is relativelythin while still attaining sufficient anchoring strength for insuringthat the fastening devices may not be easily extracted from tissue. Thecurved surgical fastening devices may be used to penetrate surgical meshand affix to soft tissue anatomical structures, such as a Cooper'sligament or fascia that cover bone. The barbs projecting from the curvedmembers provide additional anchoring force.

In one embodiment, the applicator instrument of the present inventionmay be used to repair of a defect, such as an inguinal hernia, locatedin inguinal tissue such as the inguinal floor. Generally, an inguinalhernia may be accessed through the iliacus muscle. As can be wellappreciated, a network of vessels and nerves exist in the area of atypical inguinal hernia, which requires a surgeon to conduct a herniarepair with great skill and caution. For instance, in the transverseabdominis aponeurosis, an internal ring permits gastric vessels and Vasdeferens to extend therethrough over an edge of inguinal ligament. Afemoral canal is located near the Cooper's ligament and containsexternal iliac vessels and inferior epigastric vessels.

In many cases, the edge of the inguinal ligament and the Cooper'sligament serve as anatomical landmarks and support structures forsupporting surgical fasteners such as those mentioned previously. Thearea containing the external iliac vessels and the Vas deferens may becommonly known as “the Triangle of Doom” to surgeons. Accordingly, caremust be taken when performing dissection, suturing or fastening withinthis area.

A prosthetic or a surgical mesh patch may be placed over the inguinalhernia. The mesh patch may have any desired configuration, structure ormaterial. In one embodiment, the mesh patch may be made of PROLENE™ (awell-known polymer made of fibers) and preferably configured as mesh.

The mesh patch may be placed over the inguinal hernia for providing asufficient barrier to internal viscera (not shown) of the abdomen whichwould otherwise have a tendency to protrude through the inguinal herniaand cause the patient a great deal of pain and discomfort. After themesh patch has been placed onto the inguinal floor, the mesh patch isready for attachment to the inguinal floor. The curved surgicalfastening devices disclosed herein are desirably utilized for attachingthe mesh to the inguinal floor.

The headings used herein are for organizational purposes only and arenot meant to limit the scope of the description or the claims. As usedthroughout this application, the word “may” is used in a permissivesense (i.e., meaning having the potential to), rather than the mandatorysense (i.e., meaning must). Similarly, the words “include”, “including”,and “includes” mean including but not limited to. To facilitateunderstanding, like reference numerals have been used, where possible,to designate like elements common to the figures.

While the foregoing is directed to embodiments of the present invention,other and further embodiments of the invention may be devised withoutdeparting from the basic scope thereof. As such, the scope of thepresent invention is to be limited only as set forth in the appendedclaims.

What is claimed is:
 1. A curved surgical fastener for anchoring medicaldevices to tissue comprising: a curved member having a proximal end anda distal end; and a tissue penetrating end at said distal end of saidcurved member, wherein said curved member has a total curvature of lessthan 360 degrees between said proximal and distal ends.
 2. The curvedsurgical fastener as claimed in claim 1, wherein said curved member liesin a single plane.
 3. The curved surgical fastener as claimed in claim1, wherein said tissue penetrating end is curved.
 4. The curved surgicalfastener as claimed in claim 1, wherein said curved member comprises acompound curve.
 5. The curved surgical fastener as claimed in claim 4,wherein a proximal section of said curved member has a first radius ofcurvature and a distal section of said curved member has a second radiusof curvature that is different than said first radius of curvature. 6.The curved surgical fastener as claimed in claim 1, wherein saidproximal end of said curved member comprises a tang.
 7. The curvedsurgical fastener as claimed in claim 6, wherein said tang is straight.8. The curved surgical fastener as claimed in claim 1, furthercomprising a barb projecting from said distal end of said curved member.9. The curved surgical fastener as claimed in claim 8, wherein said barbprojects from said tissue penetrating end at said distal end of saidcurved member.
 10. The curved surgical fastener as claimed in claim 9,wherein said barb projects toward said proximal end of said curvedmember.
 11. The curved surgical fastener as claimed in claim 1, whereinsaid proximal end of said curved member lies in a first plane and saiddistal end of said curved member lies is a second plane, and whereinsaid curved member has an intermediate section that extends between saidfirst and second planes.
 12. The curved surgical fastener as claimed inclaim 11, further comprising a second barb projecting from said proximalend of said curved member.
 13. The curved surgical fastener as claimedin claim 12, wherein said second barb projects toward said distal end ofsaid curved member.
 14. The curved surgical fastener as claimed in claim13, further comprising at least one supplemental barb projecting fromsaid intermediate section of said curved member.
 15. The curved surgicalfastener as claimed in claim 14, wherein said at least one supplementalbarb comprises a plurality of barbs projecting from said intermediatesection of said curved member.
 16. A curved surgical fastener foranchoring medical devices to tissue comprising: a curved member having aproximal end and a distal end; and a curved tissue penetrating end atsaid distal end of said curved member; a barb projecting from saiddistal end of said curved member; wherein said curved member has a totalcurvature of less than 360 degrees between said proximal and distalends, and wherein a proximal section of said curved member has adifferent radius of curvature than a distal section of said curvedmember.
 17. The curved surgical fastener as claimed in claim 16, whereinsaid curved member defines a compound curve with said proximal end ofsaid curved member lying in a first plane and said distal end of saidcurved member lying in a second plane that is offset from the firstplane.
 18. The curved surgical fastener as claimed in claim 16, furthercomprising a straight tang connected with said proximal end of saidcurved member.
 19. The curved surgical fastener as claimed in claim 18,wherein said proximal end of said curved member comprises a second barbprojecting therefrom that projects toward said distal end of said curvedmember.
 20. A curved surgical fastener for anchoring medical devices totissue comprising: a curved member having a proximal end and a distalend; said curved member defining a compound curve and having a totalcurvature of less than 360 degrees between said proximal and distal endsof said curved member; and said distal end of said curved memberincluding a tissue penetrating end having an insertion tip with a distalpoint.